A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects
1 other identifier
interventional
54
1 country
1
Brief Summary
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
November 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2023
CompletedSeptember 13, 2023
September 1, 2023
5 months
October 3, 2022
September 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Up to Day 14
Secondary Outcomes (14)
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334
before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334
before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334
before and at pre-specified time points up to 144 hours after dosing
- +9 more secondary outcomes
Study Arms (6)
Part A: SAD Cohorts 1-5 ABI-4334 Tablet
EXPERIMENTALA single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts.
Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet
PLACEBO COMPARATORA single dose of placebo matching ABI-4334 will be administered on Day 1.
Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet
EXPERIMENTALA single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5.
Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet
PLACEBO COMPARATORA single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6.
Part B: MAD Cohorts 1-2 ABI-4334 Tablet
EXPERIMENTALOnce-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts.
Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet
PLACEBO COMPARATOROnce-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8.
Interventions
ABI-4334 Tablet
Placebo to ABI-4334 Tablet
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
- Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
- Agreement to comply with protocol-specified contraceptive requirements
You may not qualify if:
- Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody
- History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
- History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Zealand Clinical Research
Grafton, Auckland, 1010, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Gane
New Zealand Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 6, 2022
Study Start
November 11, 2022
Primary Completion
April 12, 2023
Study Completion
April 12, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share